Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

Relapsed Small Cell Lung Cancer Clinical Trial

Official title:
A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)

Status Recruiting

Clinical Trial Summary

This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)

Clinical Trial Description

A multicenter, randomized, open-label, parallel study was designed to evaluate the efficacy and safety of LY01610 versus topotecan in the second-line treatment of patients with recurrent SCLC who were diagnosed by histopathology and/or cytology and had disease progression after first-line platinum-based chemotherapy, to conduct a population pharmacokinetics (PopPk) study, and to explore the effect of genetic polymorphisms on the pharmacokinetics properties, efficacy and safety of this product. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06128837
Study type	Interventional
Source	Luye Pharma Group Ltd.
Contact	yuankai shi, doctor
Phone	8610-87788293
Email	syuankaipumc@126.com
Status	Recruiting
Phase	Phase 3
Start date	March 3, 2024
Completion date	October 2028

View Details

See also
Status	Clinical Trial	Phase
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Terminated	`NCT03406715` - Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)	Phase 2
Withdrawn	`NCT04543916` - Venetoclax and Irinotecan in Relapsed/Refractory SCLC	Phase 1/Phase 2
Recruiting	`NCT05153239` - Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)	Phase 3
Completed	`NCT04421352` - Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients	Phase 1
Recruiting	`NCT04757779` - A Single-arm, Phase Ⅱ Clinical Trial of Anlotinib Hydrochloride Combined With Irinotecan or Docetaxel for Second Line Treatment of Nonsensitive Relapsed Small-cell Lung Cancer	Phase 2